Indications for Use of the Theradome™ LH80 PRO
The Theradome™ LH80 PRO is an over-the-counter (OTC) medical device clinically proven to promote hair growth in women with androgenetic alopecia, having Savin hair loss scale classification I-1, I-2, I-3, I-4, II-1, II-2 and Fitzpatrick skin types 1 to 4.
DO NOT stare directly at the light or its reflection off a mirror-like surface. Prolonged eye exposure can harm your eyes.
DO NOT use the charger if the cable or plug is damaged.
DO NOT use the Theradome™ LH80 PRO or its power supply if either has been exposed to water or liquid.
DO NOT use the Theradome™ LH80 PRO as a head protective device. The Theradome™ LH80 PRO is not intended to be used in this manner.
DO NOT place or store the Theradome™ LH80 PRO or charging system near any water or liquid. If exposed to any liquid substance, unplug the device immediately from the power outlet. If the helmet has been dropped into water or any type of liquid,
DO NOT attempt to pick up the helmet, and DO NOT come into contact with the substance(s).
Keep the Theradome™ LH80 PRO away from children and pets.
DO NOT use the Theradome™ LH80 PRO when your hair is wet.
DO NOT use the Theradome™ LH80 PRO if you are pregnant or breastfeeding unless specifically approved by your physician.
DO NOT modify or repair this equipment. This device has no user servicable parts.
Use the product ONLY for its intended use as described in the manual.
DO NOT drop or insert objects into any vents or openings of the device. The helmet’s lights are electrostatic discharge sensitive.
DO NOT expose the underside of the Theradome™ LH80 PRO to static or other high voltage sources.
DO NOT use a mirror or lens to direct the light toward the eye as it will increase potential eye hazards.
DO NOT charge the Theradome™ in an outlet that is blocked by furniture or isn’t easily accessible in case of a hazard.
When using the Theradome™ LH80 PRO, ALWAYS exercise caution in order to avoid: 1) strangulation due to charging cables; 2) potential allergic reactions to helmet and equipment materials and 3) contact injuries.
DO NOT use accessories, detachable parts and materials for purposes unrelated to the proper use of the Theradome™ LH80 PRO.
To avoid overheating during treatment, ALWAYS use your Theradome™ LH80 PRO away from any heat sources, including sunlight.
To avoid damage or possible injury, do NOT store your Theradome™ LH80 PRO in dusty, humid, or soiled areas, or in any environment that has a freezing temperature (below 0° C).
Using Theradome™ near other electronic devices does not pose significant risk for electromagnetic interference.
Only the Theradome™ charger should be used to charge the Theradome
For Health Care Professional: CONTRAINDICATIONS
Theradome™ Light Helmets shall not be used in case of treatment with photosensitizing medications or any type of therapy that sensitizes the skin to light exposure.
Theradome™ Light Helmets shall not be used in case of current or past scalp cancer. The coherent-light stimulates activity in both healthy and unhealthy cells.
Theradome™ Light Helmets shall not be used by pregnant or breastfeeding women unless specifically approved by the physician.
Theradome™ Light Helmets shall not be used by patients with an Ommaya reservoir under their scalp without the approval of a specialist.
Instruct your patients to discontinue use AT ONCE should the Theradome™ LH80 PRO appear to be malfunctioning.
FDA 510(K) K122950